SVENSK STANDARD
SS-EN ISO 18369-1:2017
Fastställd/Approved: 2017-10-06 Publicerad/Published: 2017-10-18 Utgåva/Edition: 2
Språk/Language: engelska/English ICS: 11.040.70
Ögonoptik – Kontaktlinser –
Del 1: Ordlista, klassifikationssystem och rekommendationer för märkning av specifikationer (ISO 18369-1:2017)
Ophthalmic optics – Contact lenses –
Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2017)
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Europastandarden EN ISO 18369-1:2017 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 18369-1:2017.
Denna standard ersätter SS-EN ISO 18369-1:2006, utgåva 1 och SS-EN ISO 18369-1:2006 / A1:2009, utgåva 1.
The European Standard EN ISO 18369-1:2017 has the status of a Swedish Standard. This document contains the official version of EN ISO 18369-1:2017.
This standard supersedes the Swedish Standard SS-EN ISO 18369-1:2006, edition 1 and SS-EN ISO 18369-1:2006 / A1:2009, edition 1.
Denna standard är framtagen av kommittén för Ögonoptik, SIS / TK 336.
Har du synpunkter på innehållet i den här standarden, vill du delta i ett kommande revideringsarbete eller vara med och ta fram andra standarder inom området? Gå in på www.sis.se - där hittar du mer information.
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EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 18369-1
September 2017
ICS 11.040.70 Supersedes EN ISO 18369-1:2006
English Version
Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling
specifications (ISO 18369-1:2017)
Optique ophtalmique - Lentilles de contact - Partie 1:
Vocabulaire, système de classification et recommandations pour l'étiquetage des spécifications
(ISO 18369-1:2017)
Augenoptik - Kontaktlinsen - Teil 1: Begriffe, Einteilung von Kontaktlinsenmaterialien und Empfehlungen für
die Schreibweise von Kontaktlinsenspezifikationen (ISO 18369-1:2017)
This European Standard was approved by CEN on 1 July 2017.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION C O M I T É E UR O P É E N DE N O R M A L I SA T I O N E UR O P Ä I SC H E S KO M I T E E F ÜR N O R M UN G
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved
worldwide for CEN national Members. Ref. No. EN ISO 18369-1:2017 E
SS-EN ISO 18369-1:2017 (E)
This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-8028865
European foreword ...iv
Introduction ...v
1 Scope ...1
2 Normative references ...1
3 Terms, definitions and symbols ...1
3.1 Terms and definitions ...1
3.2 Symbols ...38
4 Classification of contact lens materials ...39
Annex A (informative) Specification of rigid contact lenses ...42
Annex B (informative) Specification of soft contact lenses ...52
Bibliography ...54
Alphabetical index of terms ...56
iii
Contents
PageSS-EN ISO 18369-1:2017 (E)
iv
European foreword
This document (EN ISO 18369-1:2017) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2018, and conflicting national standards shall be withdrawn at the latest by March 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18369-1:2006.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 18369-1:2017 has been approved by CEN as EN ISO 18369-1:2017 without any modification.
SS-EN ISO 18369-1:2017 (E)
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Introduction
The ISO 18369 series applies to contact lenses, which are devices worn over the front surface of the eye in contact with the preocular tear film. This document covers rigid (hard) corneal and scleral contact lenses, as well as soft contact lenses. Rigid lenses maintain their own shape. Soft contact lenses are easily deformable and require support for proper shape.
Clause 3 contains the terms and definitions primarily used in the contact lens field. A list of terms having special symbols is given in Table 1.
The list of terms and definitions does not include all ISO terms, definitions, and symbols used in the contact lens field. It is intended to be a convenient reference source from which the contents have been compiled from the text of this and other ISO standards applicable to the manufacture, evaluation, measurement, labelling and marketing of contact lenses and contact lens care products. An alphabetical index was added for rapid finding of terms.
Words are grouped under several topics by reference number according to the general category into which each word logically fits. The preferred form of each term is listed on the first line after its reference number. Other admitted forms have been placed on subsequent lines after the preferred form. All admitted terms are given in bold-faced type. A few obsolete and superseded terms are listed for historical reference and convenience and to aid comprehension but are indicated as deprecated and are no longer to be used. Obsolete and superseded terms are not in bold-faced type so that they may be clearly identified as terms used historically.
Contact lenses are primarily used for the correction of refractive errors but they can also be used for therapeutic purposes and cosmetic reasons. The materials used are divided into two main categories, rigid and soft. The former is composed mainly of corneal lenses and to a lesser extent, scleral lenses.
Both types can be made from gas-permeable materials or non-gas permeable materials. Soft lenses are manufactured primarily from hydrogel materials. A small number of lenses incorporate both a rigid material and a soft material.
In terms of vision correction, contact lenses can be made as single vision, bifocal, multifocal or progressive lenses. Surface designs can be spherical, aspheric, toric or “complex”.
Wearing modality can be daily wear, flexible wear, or extended wear. Typical replacement schedules for soft lenses are daily, two weekly, or monthly. Rigid lenses and some soft lenses are replaced less often, for example, once a year.
v
SS-EN ISO 18369-1:2017 (E)
Ophthalmic optics — Contact lenses — Part 1:
Vocabulary, classification system and recommendations for labelling specifications
1 Scope
This document identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when appropriate, the international symbol and abbreviation associated with a specific term. This document also defines the terms relating to contact lens care products. It also incorporates the classifications of contact lens materials and gives recommendations for the labelling of the specifications of contact lenses.
2 Normative references
There are no normative references in this document.
3 Terms, definitions and symbols
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp 3.1 Terms and definitions
3.1.1 Basic terms 3.1.1.1
contact lens
ophthalmic lens designed to be worn on the front surface of the eye Note 1 to entry: This term includes contact lenses of plano power.
3.1.1.2
corneal contact lens intralimbal contact lens
contact lens (3.1.1.1) having a total diameter less than the visible iris diameter and designed to be worn in its entirety on the cornea
3.1.1.3
scleral contact lens
contact lens (3.1.1.1) whose scleral zone (3.1.5.12) is supported on the bulbar conjunctiva and whose optic zone (3.1.2.1.17) vaults over the cornea
Note 1 to entry: Note1 to entry: In some cases, the back optic zone (3.1.2.2.1) will have minimal corneal touch.
Note 2 to entry: Terms such as mini-scleral, semi-scleral and corneo-scleral can be found in the contact lens literature to describe lenses of different parameters.
1 SS-EN ISO 18369-1:2017 (E)
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Note 3 to entry: See 3.1.5 for specific terms concerning scleral contact lenses.
3.1.1.4
lenticular contact lens
contact lens (3.1.1.1) having a front optic zone (3.1.2.1.17) made smaller than the total diameter
Note 1 to entry: This construction is conventionally used to reduce the centre thickness (3.1.2.4.1) of a positive power contact lens (3.1.2.1.13) or reduce the edge (3.1.2.1.34) thickness of a negative power contact lens (3.1.2.1.14).
3.1.1.5 contact shell
contact lens (3.1.1.1) not designed to correct vision 3.1.1.6
scleral shell
rigid contact shell (3.1.1.5) with a scleral zone (3.1.5.12)
Note 1 to entry: See 3.1.5 for specific terms concerning scleral shells.
3.1.1.7
rigid contact lens
contact lens (3.1.1.1) which, in its final state and under normal conditions, retains its form without support and has a water content (3.1.6.11) less than 10 %
Note 1 to entry: Rigid lenses are made of non-hydrogel rigid materials which can flex slightly but do not substantially conform to the shape of the cornea when on the eye.
3.1.1.8
rigid gas-permeable contact lens RGP contact lens
DEPRECATED: hard gas-permeable contact lens
contact lens (3.1.1.1) manufactured from a rigid material containing one or more gas-permeable polymers in sufficient concentrations to facilitate transport of oxygen through the lens and having a Dk equal to or greater than 10 Dk units
Note 1 to entry: For an explanation of the meaning of Dk and Dk units, see 3.1.6.8.
3.1.1.9
soft contact lens
contact lens (3.1.1.1) made of a hydrogel material or non-hydrogel material which, in its hydrated final state and under normal conditions, contains a known water content (3.1.6.11), is easily deformable and may not retain its form without support
3.1.1.10
hydrogel contact lens
DEPRECATED: hydrophilic contact lens
contact lens (3.1.1.1) made of water-absorbing material having equilibrium water content (3.1.6.11) greater than or equal to 10 % in standard saline solution as specified in ISO 18369–3 at 20 °C
3.1.1.11
composite contact lens
contact lens (3.1.1.1) composed of two or more different materials
EXAMPLE Laminated lens, fused segment lens, lens with a rigid centre and a flexible periphery.
3.1.1.12
surface-treated contact lens
contact lens (3.1.1.1) whose surfaces have been modified to make the surface characteristics different to those of the bulk material
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SS-EN ISO 18369-1:2017 (E)
3.1.1.13
bifocal contact lens
multifocal contact lens (3.1.1.14) having two optic zones (3.1.2.1.17), usually for distance and near-vision correction
Note 1 to entry: See 3.1.4 for specific terms concerning bifocal contact lenses.
3.1.1.14
multifocal contact lens
contact lens (3.1.1.1) designed to provide two or more zones of different corrective powers Note 1 to entry: See 3.1.4 for specific terms concerning multifocal contact lenses.
3.1.1.15
progressive power contact lens varifocal power contact lens
contact lens (3.1.1.1) designed to provide correction for more than one viewing range in which the power changes continuously, rather than discretely, over a part or the whole of the lens
Note 1 to entry: See 3.1.4 for specific terms concerning progressive power contact lenses.
3.1.1.16
spherical aberration
attribute of an optical system due to variation in the focusing between peripheral and paraxial rays 3.1.1.17
contact lens accessory
article intended specifically by its manufacturer to be used with a contact lens (3.1.1.1) to enable the lens to be used in accordance with its intended purpose (3.1.9.1)
Note 1 to entry: This term includes all devices to clean, handle, store or manipulate lenses for intended use.
Note 2 to entry: This definition does not include the primary packaging (3.1.9.7), e.g. vials, blister packs (3.1.9.5) or mailers, intended by the manufacturer to be used only for shipment of the contact lenses.
3.1.1.18
contact lens care product
contact lens accessory (3.1.1.17) intended for use in maintaining the safety and performance (3.1.9.2) of a contact lens (3.1.1.1) after opening and removal of the lens from its primary container (3.1.9.7)
Note 1 to entry: See 3.1.9 and 3.1.11 for specific terms concerning contact lens care products and the hygienic management of contact lenses.
3.1.1.19 suction cup
handheld device designed with a small concave flexible tip intended to aid the insertion of a contact lens (3.1.1.1) onto or removal from the eye by means of suction
Note 1 to entry: A suction cup is designed primarily for use with rigid corneal contact lenses (3.1.1.2) and scleral contact lenses (3.1.1.3).
3.1.1.20
contact lens container storage container contact lens case storage case
device in which contact lenses (3.1.1.1) are stored either dry (rigid corneal and scleral lenses), or in a suitable solution (rigid gas permeable lenses, hydrogel and other soft lenses), by the user after removal from the primary container (3.1.9.7) or the eye
3 SS-EN ISO 18369-1:2017 (E)
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